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Positron Emission Tomography(PET) in Lymphoma Assessment

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ClinicalTrials.gov Identifier: NCT00887718
Recruitment Status : Completed
First Posted : April 24, 2009
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
This study examines the role of a diagnostic test called Positron Emission Tomography (PET) scanning in patients with malignant lymphoma. The primary goal of this study is to find out how well PET scanning can detect malignant (cancerous) lymphoma, and how often this extra information will result in a change of stage of disease, or will result in a change in treatment management plans of patients with lymphoma.

Condition or disease Intervention/treatment
Hodgkin's Lymphoma Non Hodgkin's Lymphoma Biological: PET Scan

Detailed Description:
It is currently unknown whether modifying treatment based on FDG-PET results is appropriate. However, clinicians are increasingly using the FDG-PET result, where obtained, in deciding management. Consequently, it would be premature to mandate PET-based treatment modifications in this protocol. Patients will be treated with existing protocols at the discretion of their treating oncologists, based on available information. Oncologists will be surveyed as to whether FDG-PET scan results could have (or affect patient management, and the intervention will be recorded).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Positron Emission Tomography for Staging, and Treatment Assessment of Response in Lymphomas (the Pet-star Lymphoma Study)
Study Start Date : August 2007
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PET scan for lymphoma assessment Biological: PET Scan
18F-Fluorodeoxyglucose (FDG) injection



Primary Outcome Measures :
  1. To determine:the frequency in which the FDG-PET scan result will change the clinical management of the patient, and to record the intervention instituted within 3 months of the PET scan 2)early relapse rates for PET positive, and PET negative patients. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To:1) describe & quantify potential changes in clinical practice caused by the adoption of FDG-PET scanning 2)correlate FDG-PET scan findings with disease characteristics, traditional standard response criteria, biopsy results, & early clinical outcome. [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Group A: Newly Diagnosed

Inclusion Criteria:

  • Patients > 18 years of age.
  • Confirmed diagnosis of HL or NHL (any histology).
  • Any Ann Arbor stage.
  • Pre-treatment staging including CT of head and neck, chest, abdomen and pelvis, where there is a minimum one equivocal finding on the scan, affecting the assignment of stage or IPI factor (i.e. stage III/IV vs. stage I/II, or a question of extranodal involvement by disease).

Group B: Response Assessment

Inclusion Criteria:

  • Patients > 18 years of age.
  • Confirmed diagnosis of HL or NHL (any histology).
  • Any Ann Arbor stage.
  • Pre-treatment staging including CT neck, chest, abdomen and pelvis. If alternate assessment of the neck done by clinical palpitation, ultrasound, or MRI is negative, CT neck is not mandatory.
  • Post-treatment staging including CT of head and neck, chest, abdomen and pelvis, at 1 - 6 weeks post-therapy.
  • Treated with anthracycline-based chemotherapy, with or without radiation therapy (based on the stage of the disease). For Stage III/IV patients, PET will be done following completion of primary chemotherapy. For stage I/II patients, PET will be done after combined modality therapy, or after chemotherapy alone if this was the primary intention of therapy.
  • Patients with residual mass on CT following primary chemotherapy with either "unconfirmed" CR (>75% decrease in size) or PR (³50% decrease in size), based on International workshop criteria.

Exclusion Criteria: Response Assessment

  • None Curative treatment Intent
  • After initial therapy the response status is: complete response, stable disease, or progressive disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887718


Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Richard Tsang, MD University Health Network, Princess Margaret Hospital

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00887718     History of Changes
Other Study ID Numbers: UHN REB 07-0235-C
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by University Health Network, Toronto:
PET scan and Hodgkin's Lymphoma
PET scan and Non Hodgkin's Lymphoma
PET scan

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases